FDA 510(k) Searchable Database - Search 174,000+ Clearances

Search 174,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code — with real review time data, denied submission rates and regulatory intelligence no other searchable 510(k) database provides.

175,730 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
175,230 results
155353–155376 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Oct 14, 1983
SERALYZER AST/SGOT REAGENT STRIPS
K832790 · CIF
Miles Laboratories, Inc.
Chemistry · 59d
Cleared Oct 14, 1983
SERAYZER ALT/SGPT REAGENT STRIPS
K832791 · CKC
Miles Laboratories, Inc.
Chemistry · 56d
Cleared Oct 14, 1983
MODIFICA-OF EMIT AED PRIMIDONE ASSAY
K832798 · DJD
Syva Co.
Toxicology · 57d
Cleared Oct 14, 1983
MODIFICA- OF EMIT CAD LIDOCAINE ASSAY
K832799 · KLR
Syva Co.
Toxicology · 57d
Cleared Oct 14, 1983
URETERAL DILATION SET
K832808 · EZN
Van-Tec, Inc.
Gastroenterology & Urology · 57d
Cleared Oct 14, 1983
FIAX IGG TEST
K832821 · DFI
Intl. Diagnostic Technology
Immunology · 56d
Cleared Oct 14, 1983
CLOSED SYS. DRAINAGE BAGS & TRAYS
K832822 · KNX
Medline Industries, Inc.
Gastroenterology & Urology · 56d
Cleared Oct 14, 1983
ENZYMUNE-TEST TSH
K832823 · JLW
Icl Scientific
Chemistry · 56d
Cleared Oct 14, 1983
LIPASE HYDROLYSIS/GLYCEROL KINASE
K832871 · CDT
Pointe Scientific, Inc.,
Chemistry · 50d
Cleared Oct 14, 1983
HEXOKINASE, GLUCOSE
K832872 · CFR
Pointe Scientific, Inc.,
Chemistry · 50d
Cleared Oct 14, 1983
GOAL TENDER
K832878 · BWF
Dna Medical, Inc.
Anesthesiology · 49d
Cleared Oct 14, 1983
LUNDIA 10-2-L PARALLEL PLATE HEMODIALY
K832894 · KOC
Gambro, Inc.
Gastroenterology & Urology · 49d
Cleared Oct 14, 1983
LEGIONELLA INDIRECT FLUORESCENT ANTIBOD
K832896 · LHL
Biodan Medical Systems, Ltd.
Immunology · 52d
Cleared Oct 14, 1983
ZIMMER OSSIMETER
K832899 · FTY
Zimmer, Inc.
General & Plastic Surgery · 46d
Cleared Oct 14, 1983
CEFUROXIME 30MCG. SENSITIVITY DISCS
K832909 · JTN
Difco Laboratories, Inc.
Immunology · 46d
Cleared Oct 14, 1983
URETHRAL OBSTRUCT PRIMARY EXCHANGE STEN
K832915 · FAD
Surgitek
Gastroenterology & Urology · 46d
Cleared Oct 14, 1983
GRAVITY ENTERAL FEEDING SET
K832927 · KNT
Medical Connections
Gastroenterology & Urology · 51d
Cleared Oct 14, 1983
SHABAN #9852 CHIMNEY-#9854 SCREEN &
K832931 · JJO
Shaban Mfg. Co.
Chemistry · 45d
Cleared Oct 14, 1983
SHABAN #9858 ASPIRATOR ASSEMBLE #9862-
K832932 · JJO
Shaban Mfg. Co.
Chemistry · 45d
Cleared Oct 14, 1983
SHABAN #9850 PUMP WINDINGS-9860 FILTER
K832936 · JJO
Shaban Mfg. Co.
Chemistry · 45d
Cleared Oct 14, 1983
SHABAN #9868 TUBING KIT-9870 STYLET
K832937 · JJO
Shaban Mfg. Co.
Chemistry · 45d
Cleared Oct 14, 1983
DALE ENDOTRACHEAL TUBE HOLDER
K832946 · JAY
Dale Medical Products, Inc.
Anesthesiology · 42d
Cleared Oct 14, 1983
CEFTIZOLIME 30 MCG SENSI-DISC
K832956 · JTN
Bd Becton Dickinson Vacutainer...
Microbiology · 44d
Cleared Oct 14, 1983
MAXITHINS UNSCENTED PANTY SHIELDS
K832974 · HHD
Tampax, Inc.
Obstetrics & Gynecology · 43d